Field of the Invention and Description of the Prior Art
This invention is concerned with dosage forms containing an active ingredient for human ingestion. More specifically, it is concerned with edible dosage unit forms which comprise soft elastic gelatin (SEG) capsule shells encapsulating an active ingredient.
Pharmaceutical compositions in dosage unit form encapsulated in SEG capsules are well known and generally consist of a fill material comprising one or more active ingredients dissolved or suspended in an appropriate liquid or paste vehicle encapsulated in a soft gelatin shell, typically comprising gelatin together with a plasticizer. Standard gelatin used to manufacture soft elastic gelatin capsules has a yellow coloration inherent from the manufacturing process. Thus, when an SEG capsule is produced with a colorless transparent fill material and a standard gelatin, capsules appear visually as a clear amber to yellow color. The interior liquid in the capsule can be a single or a multi-component system; in either case it must be chemically compatible with the SEG capsule.
Particularly in recent years, ingredient adulteration of ingestible dosage forms, especially pharmaceuticals, has come to public attention as a risk inherent in ingesting over-the-counter and prescription drugs. Manufacturers' approaches to deal with this problem have generally involved some form of seal on the medication's package, so that the seal will give evidence of having been broken if the product has been tampered with. Examples of such seals include shrink wrapping the entire container, placing a tab seal across the junction between the cap or top and the side of the container, and enclosing the neck of a bottle at the cap/bottle interface in a continuous loop of tightly applied plastic film. Some containers have also been designed with a pop up indicator that moves from a position flush with the rest of the package to a raised position to indicate when the package has been opened.
At the dosage form level, one alternative is two piece hardshell capsules which are sealed with a shrunken band to prevent separation of the two pieces.
In the separate field of cosmetics, packages are less strictly monitored for adulteration than pharmaceutical dosage form packages because the former products are not intended for ingestion. A wide variety of packaging is used in cosmetics, such as compacts, atomizers, boxes, slide tubes, tins, colored pencils, and jars. At least one cosmetic product, Elizabeth Arden's UNDER EYE CERAMIDE MOISTURIZER product has been sold in a soft gel capsule which acts exclusively as the packaging and applicator. Color neutralization techniques have been used for making this soft gel packaging, employing dyes, such as D&C Violet #5, for aesthetic purposes.